| Government proposals that could substantially change the way in which
every pharmacy in the UK is run, including registered hospital premises,
are now out for formal
consultation (PJ, 27 October 2007, p457).
If the proposals on the responsible pharmacist and supervision are
implemented, they will
allow pharmacists to be away from registered premises for up to three
hours and to delegate appropriate tasks to qualified support staff. The
aim is to make better use of pharmacists’ clinical skills and the
skills of all pharmacy staff.
The Department of Health has decided to consult first on regulations
related to the responsible pharmacist and will later seek views on regulations
concerning supervision. Supervision relates to activities at an individual
transaction level whereas the responsible pharmacist relates to activities
at an operational level.
Jeannette Howe, head of pharmacy at the DoH, told The Journal: “The
responsible pharmacist regulations will support a quality system approach,
with clear lines of accountability, procedures and appropriately trained
staff.”
Referring to the concept of the responsible pharmacist, she says: “What
we believe we are doing is recreating and clarifying what we think was
always intended [by personal control] in the Medicines Act.”
She
explains that a different term is being used because case law has previously
indicated that personal control requires the physical presence of the
pharmacist (see Panel below).
Personal control
Personal control was introduced — but never
defined — in the Medicines Act 1968 and this lack of clarity,
along with limited case law, resulted in the emergence of a common
interpretation that a pharmacist is required to be physically
present in the pharmacy at all times if he or she is to exercise
control and allow the sale and supply of medicines to continue
from the pharmacy.
This interpretation has led to anomalies. For example, a pharmacist must
be present when a general sale list medicine is purchased from a pharmacy
whereas no such requirement exists for GSL items purchased from garage
shops or newsagents.
It also constrains pharmacists’ ability to
use their clinical training to full effect by providing services away
from the dispensary and limits the use of skilled support staff.
The Health Act 2006 amends the Medicines Act 1968 and
related NHS legislation, replacing the concept of personal
control and providing for changes to
the pharmacist supervision requirements.
The amendments to the Medicines
Act allow for ministers to set out in regulations further details
of how these changes should be implemented. |
“If we had kept the term ‘personal control’ and said
this is what the law means through legislation, we think there would
still
have been confusion and doubt. But it equates to personal control,” she
says.
She adds that the changes to personal control will seem a bit limited
until the supervision requirements are also updated. Responsible pharmacist
Amendments to the Medicines Act, which will come into force when the
regulations are brought in, make it clear that the responsible pharmacist
is in charge of the day-to-day management of the pharmacy and must
ensure that it operates safely and effectively in relation to the sale
and supply of medicines regardless of whether he or she is physically
present.
“Either the pharmacy is operating safely or it is not and this is not
dependent on the pharmacist in charge of the pharmacy being physically
present in the pharmacy at all times while it is operating,” the
consultation states. This means the pharmacist’s presence is not
required when GSL medicines are being sold, unless the medicine is part
of an NHS prescription (since current supervision requirements then apply).
The current supervision requirements specify that a pharmacist must supervise
transactions involving pharmacy and
prescription-only medicines. The new supervision regulations (yet to
be consulted on) are expected to permit the responsible pharmacist to
delegate this task to suitably trained, registered support staff, which
will allow these transactions to take place in the pharmacist’s
absence.
Each pharmacy must have a responsible pharmacist whether it is operated
by an individual pharmacist, a partnership, a body corporate (including
registered hospital pharmacies) or a representative of a pharmacist.
The amendments to the Medicines Act state that the responsible pharmacist
must establish (where these are not already in place), maintain, and
review procedures for safe working in the pharmacy and keep a record,
in the pharmacy, of the pharmacist responsible for the pharmacy at any
one time.
The role of responsible pharmacist is distinct from that of superintendent
pharmacist, who has overarching responsibilities within a body corporate
to ensure that the company meets statutory, ethical and professional
requirements and standards, the consultation explains.
Mrs Howe says: “The superintendent can set company policy, guidance
and standards, and can go as far as developing model operating procedures.
But what the superintendent must allow is for the responsible pharmacist
to tailor those procedures to the particular need of that pharmacy in
terms of its staffing and workload.”
It would not be appropriate
for the superintendent to fetter the professional judgement of the
responsible pharmacist.
The amendments will also confer a statutory duty on the pharmacy owner
to ensure that the responsible pharmacist maintains the record of who
is responsible and to preserve said record for the period specified
in the regulations.
The general rule is that there must be one responsible pharmacist for
each pharmacy and that he or she can only be responsible for one pharmacy
at a time (although there may be several different responsible pharmacists
during the course of a day or week).
However, the consultation says that
the Government recognises the need for some flexibility in this to
respond to future changes in pharmacy practice and modern technologies.
Exemptions
to the general rule can therefore be set out by ministers in the
regulations.
Proposals
The consultation document contains a range of proposals and seeks views
on several issues, including:
• What should be covered in the pharmacy procedures
• The information to be included in the pharmacy record
• The ability of the responsible pharmacist to be absent from the pharmacy
• The qualifications and experience necessary to be a responsible pharmacist
• The circumstances in which a responsible pharmacist may supervise individual
transactions in a pharmacy where he or she is not the responsible pharmacist
• The timing and introduction of the responsible pharmacist regulations
and the need for guidance to support them
Proposals on the ability of the pharmacist to supervise individual transactions
from another location (remote supervision) are not included in this consultation
and will be considered along with proposals for the
content of the regulations relating to
supervision.
The Journal will be covering
each of the sections of the responsible
pharmacist consultation in detail over the coming weeks. |
The
Pharmaceutical Journal